Alzheimer’s Research UK is to sponsor a clinical trial of GW Pharmaceuticals’ Sativex to treat agitation and aggression in people with dementia.
Sativex, which is approved to treat MS, is a peppermint-flavoured mouth spray that contains a 1:1 ratio of two key cannabinoids found in the cannabis plant.
It became the first cannabis-based medicine to be licensed (as a schedule 4 drug) in the UK back in 2010, years ahead of the change in the law last November, when it became legal for specialist doctors to prescribe cannabis-based products for medicinal use.
It is authorised for the treatment of muscle stiffness and tightness experienced by those with multiple sclerosis, but it isn’t available for routine use in England as NICE judged it to be not cost-effective in 2014.
Now the oral spray will now undergo testing to examine whether it is effective for treating agitation or aggression in people with Alzheimer’s, a common problem for sufferers and their carers.
The trial, known as STAND (Sativex for the Treatment of AgitatioN in Dementia), will recruit Alzheimer’s patients (aged between 55-90) who are living in care homes and are presenting symptoms of agitation.
Dr David Reynolds, Chief Scientific Officer of Alzheimer’s Research UK, the UK’s leading dementia research charity said: “While a major focus for dementia research is to develop drugs that slow or stop the progression of the physical diseases that cause dementia, what really matters is that a medicine benefits people’s day-to-day lives.
“The STAND trial opens the door to a treatment that may help to alleviate an extremely challenging set of symptoms, and Alzheimer’s Research UK is extremely grateful to our supporters for making this important work possible.
STAND will be run by Chris Albertyn, Research Portfolio Lead at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London and if successful then plans for a much larger clinical trial will commence.
“One of the key questions the STAND trial will answer is whether it is practical to give someone with dementia a drug through a mouth spray when they may be exhibiting severe symptoms of agitation and aggression,” said Prof Dag Aarsland, the lead researcher on the STAND trial.
“We will also get some indication of whether Sativex is effective at reducing symptoms, although larger studies will be needed to get firm evidence of this.”
There have been no new treatments for dementia for the last 15 years, and Albertyn warns that current treatments for behavioural and psychiatric symptoms of the disease are very limited.
He adds: “We desperately need to develop alternative treatments. Doctors sometimes prescribe anti-psychotic medications, and while these drugs can have important benefits, these need to be weighted against the risk of very serious side effects.”
Meanwhile, there have been some movements that suggest access to cannabis-based medicines could be easier to access within the UK. Just earlier this week medical cannabis firm Althea announced it is to enter the UK market and will start supplying products as of next month.